US-IL-McGawPark: Sr Principal Quality Engineer
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Sr Principal Quality Engineer - Application Software
The Senior Principal Quality Engineer (Application Software) works as a member of one or more project teams engaged in new product development and/or product sustaining related to application software development for medical device systems.
Serving as a quality representative on the software project team and working closely with the Core Team Leader, this individual is responsible for ensuring each project is developed and released meeting customer expectations and regulatory requirements related to application software.
He or she will work closely with product engineering to ensure successful design, development, testing and transfer and provides support to sustaining engineering.
Bachelorís degree in Engineering or Computer Science required
Candidate must have:
* Experience on a product development team releasing an application software product to market for a highly regulated industry. Medical device preferred
* Professional certification such as ASQ, IEEE, Six Sigma, LEAN manufacturing or achievement of certification within two years. ASQ CSQE preferred
* Thorough understanding of regulations, standards, guidance documents and best practices for application software development in a highly regulated industry. FDA and IEEE preferred
* Solid understanding in the areas of design control and design change control.
* Experience with FDA inspections and ISO/Notified Body audits is a plus
* Ability to work at Senior Management levels
* Strong communication and leadership skills.
* Strong, results driven, project management skills.
* Detailed knowledge of application software development, quality assurance and verification and validation testing
* In-depth understanding of software development lifecycles
* Excellent presentation skills
* Excellent problem solving skills and
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI